Acute Ischemic StrokeNCT07422649
Anesthesia Technique and Outcomes in Mechanical Thrombectomy for Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective cohort study examined clinical outcomes in patients who underwent mechanical thrombectomy for acute ischemic stroke under general anesthesia or sedoanalgesia. Patient data from 2014 to 2018 were obtained from hospital medical records. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- General Anesthesia and Sedoanalgesia
- How many people
- 481 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 5 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with acute ischemic stroke who underwent mechanical thrombectomy at the University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital between 2014 and 2018. Patients were treated within 6 hours of symptom onset and achieved successful angiographic reperfusion. Based on anesthesia records, patients were categorized according to anesthesia management as general anesthesia or sedoanalgesia.
Who may be able to join
- Age ≥18 years
- Acute ischemic stroke due to large vessel occlusion (MCA M1)
- Mechanical thrombectomy performed within 6 hours of symptom onset
- Pre-procedural TICI score 0-1
Who cannot join
- Age ≥100 years
- APACHE II score of 25 or higher
- Glasgow Coma Scale score below 10
- Requirement for endotracheal intubation before the procedure
- Patients discharged from the procedure to the intensive care unit while intubated
- Time from symptom onset to procedure exceeding 6 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatma Acil
Diyarbakır, Outside of the US, 21070
About this study
Official title: Comparison of General Anesthesia and Sedoanalgesia on Mortality and Neurological Outcomes in Patients Undergoing Mechanical Thrombectomy for Acute Ischemic Stroke
This retrospective cohort study examined clinical outcomes in patients who underwent mechanical thrombectomy for acute ischemic stroke under general anesthesia or sedoanalgesia. Patient data from 2014 to 2018 were obtained from hospital medical records. Mortality and neurological outcomes were compared between anesthesia groups.
Read the detailed description
This retrospective observational cohort study was conducted at the University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Medical records of patients who underwent mechanical thrombectomy for acute ischemic stroke between 2014 and 2018 were reviewed. Patients who received mechanical thrombectomy within 6 hours of symptom onset and achieved a Thrombolysis in Cerebral Infarction (TICI) reperfusion grade of 2a, 2b, or 3 were included. Patients with TICI grades of 0 or 1, those younger than 18 years, patients with an APACHE II score ≥25, a Glasgow Coma Scale score <10, those requiring endotracheal intubation before the procedure, or patients discharged from the procedure intubated to the intensive care unit were excluded.
Based on anesthesia records, patients were classified into two cohorts: those who underwent the procedure under general anesthesia and those managed with sedoanalgesia. No assignment to anesthesia technique was performed as part of the study, and anesthesia management was determined according to routine clinical practice. Demographic characteristics, medical history, radiological findings, procedural details, and perioperative variables were extracted from hospital records. Neurological status was assessed using the National Institutes of Health Stroke Scale (NIHSS) at 4 and 24 hours after the procedure, and functional outcome was evaluated using the modified Rankin Scale during hospitalization and at 3 months after thrombectomy. Intraoperative bispectral index (BIS) values and cerebral oxygenation measured by near-infrared spectroscopy (NIRS) were recorded when available. Safety outcomes including peri-procedural hemodynamic instability, vasopressor or antihypertensive use, need for pacing, and intensive care unit (ICU) length of stay will be evaluated.
Neurological outcomes will be assessed longitudinally using NIHSS at baseline, 4 hours, 24 hours, and modified Rankin Scale (mRS/TICI) immediately after the procedure and at 3 months.
The primary outcome of the study was all-cause mortality. Secondary outcomes included neurological and functional outcomes, perioperative variables, intensive care unit length of stay, and procedure-related complications. Comparisons between anesthesia cohorts were performed using routinely collected clinical data. Postoperative delirium occurring during the first 7 days after the procedure was evaluated as a secondary safety outcome when documented in the medical records
- Conditions
- Acute Ischemic Stroke
- Being tested
- General Anesthesia, Sedoanalgesia
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, General Anesthesia, Sedoanalgesia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaOther
Patients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records.
SedoanalgesiaOther
Patients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Group | Patients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records. Receives: Other: General Anesthesia | |
| Sedoanalgesia Group | Patients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records. Receives: Other: Sedoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Comparison of all-cause mortality between patients undergoing mechanical thrombectomy under general anesthesia and sedoanalgesia.
Measured: During index hospitalization and at 3 months post-procedure
Secondary outcomes (12)
NIHSS Score
The National Institutes of Health Stroke Scale (NIHSS) is used to quantify stroke severity (score range 0-42; higher scores indicate more severe stroke)
Measured: Baseline, 4 hours, 24 hours post-procedure
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a global functional outcome measure used after stroke to categorize the level of functional independence.
Measured: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy
TICI Reperfusion Grade
The Thrombolysis in Cerebral Infarction (TICI) grading system is used after endovascular revascularization to describe angiographic reperfusion (e.g., 0-3; higher grades indicate better reperfusion)
Measured: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy.
Near-Infrared Spectroscopy (NIRS) Values
Regional cerebral oxygen saturation was monitored using near-infrared spectroscopy (NIRS) during the procedure and throughout the early postoperative period.
Measured: During index hospitalization and at 3 months post-procedure
Bispectral Index (BIS) Values
Depth of anesthesia was monitored using bispectral index (BIS) values recorded during the procedure.
Measured: During the procedure
Procedure Duration
Total duration of the mechanical thrombectomy procedure.
Measured: During the procedure
Time From Symptom Onset to Procedure
Elapsed time between symptom onset and initiation of mechanical thrombectomy.
Measured: At the time of the procedure
ICU Length of Stay
Duration of stay in the intensive care unit following the procedure
Measured: Through study completion, an average of 3 months
Hemodynamic Parameters
Systolic and diastolic blood pressure values recorded during the perioperative period
Measured: From procedure until 3 months post-procedure
Procedure-Related Complications
Occurrence of neurological or procedure-related complications during hospitalization
Measured: During hospitalization
Postoperative delirium
Incidence of postoperative delirium during the first 3 postoperative months
Measured: Within 30 days after procedure
Postoperative demans
Incidence of postoperative delirium during the first 3 postoperative months
Measured: Within 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Apr 2026
- Primary completion4 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422649
- Sponsor's protocol ID
- 01/20/2026- 13
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of General Anesthesia and Sedoanalgesia on Mortality and Neurological Outcomes in Patients Undergoing Mechanical Thrombectomy for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07422649
- Acronym / sponsor ID
- 01/20/2026- 13
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, General Anesthesia, Sedoanalgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective cohort study examined clinical outcomes in patients who underwent mechanical thrombectomy for acute ischemic stroke under general anesthesia or sedoanalgesia. Patient data from 2014 to 2018 were obtained from hospital medical records. Mortality and neurological outcomes were compared between anesthesia groups.
Detailed description
This retrospective observational cohort study was conducted at the University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Medical records of patients who underwent mechanical thrombectomy for acute ischemic stroke between 2014 and 2018 were reviewed. Patients who received mechanical thrombectomy within 6 hours of symptom onset and achieved a Thrombolysis in Cerebral Infarction (TICI) reperfusion grade of 2a, 2b, or 3 were included. Patients with TICI grades of 0 or 1, those younger than 18 years, patients with an APACHE II score ≥25, a Glasgow Coma Scale score <10, those requiring endotracheal intubation before the procedure, or patients discharged from the procedure intubated to the intensive care unit were excluded.
Based on anesthesia records, patients were classified into two cohorts: those who underwent the procedure under general anesthesia and those managed with sedoanalgesia. No assignment to anesthesia technique was performed as part of the study, and anesthesia management was determined according to routine clinical practice. Demographic characteristics, medical history, radiological findings, procedural details, and perioperative variables were extracted from hospital records. Neurological status was assessed using the National Institutes of Health Stroke Scale (NIHSS) at 4 and 24 hours after the procedure, and functional outcome was evaluated using the modified Rankin Scale during hospitalization and at 3 months after thrombectomy. Intraoperative bispectral index (BIS) values and cerebral oxygenation measured by near-infrared spectroscopy (NIRS) were recorded when available. Safety outcomes including peri-procedural hemodynamic instability, vasopressor or antihypertensive use, need for pacing, and intensive care unit (ICU) length of stay will be evaluated.
Neurological outcomes will be assessed longitudinally using NIHSS at baseline, 4 hours, 24 hours, and modified Rankin Scale (mRS/TICI) immediately after the procedure and at 3 months.
The primary outcome of the study was all-cause mortality. Secondary outcomes included neurological and functional outcomes, perioperative variables, intensive care unit length of stay, and procedure-related complications. Comparisons between anesthesia cohorts were performed using routinely collected clinical data. Postoperative delirium occurring during the first 7 days after the procedure was evaluated as a secondary safety outcome when documented in the medical records
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | Other: General AnesthesiaPatients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records. |
| Sedoanalgesia Group | – | Other: SedoanalgesiaPatients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with acute ischemic stroke who underwent mechanical thrombectomy at the University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital between 2014 and 2018. Patients were treated within 6 hours of symptom onset and achieved successful angiographic reperfusion. Based on anesthesia records, patients were categorized according to anesthesia management as general anesthesia or sedoanalgesia.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Acute ischemic stroke due to large vessel occlusion (MCA M1)
- Mechanical thrombectomy performed within 6 hours of symptom onset
- Pre-procedural TICI score 0-1
Key exclusion criteria (6 listed)
- Age ≥100 years
- APACHE II score of 25 or higher
- Glasgow Coma Scale score below 10
- Requirement for endotracheal intubation before the procedure
- Patients discharged from the procedure to the intensive care unit while intubated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnesthesiaPatients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records. | Other | General Anesthesia Group |
| SedoanalgesiaPatients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records. | Other | Sedoanalgesia Group |
Primary outcome
All-Cause Mortality
Time frame: During index hospitalization and at 3 months post-procedure
Comparison of all-cause mortality between patients undergoing mechanical thrombectomy under general anesthesia and sedoanalgesia.
12 secondary outcomes
NIHSS Score
Time frame: Baseline, 4 hours, 24 hours post-procedure
Modified Rankin Scale (mRS)
Time frame: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy
TICI Reperfusion Grade
Time frame: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy.
Near-Infrared Spectroscopy (NIRS) Values
Time frame: During index hospitalization and at 3 months post-procedure
Bispectral Index (BIS) Values
Time frame: During the procedure
Procedure Duration
Time frame: During the procedure
Time From Symptom Onset to Procedure
Time frame: At the time of the procedure
ICU Length of Stay
Time frame: Through study completion, an average of 3 months
Hemodynamic Parameters
Time frame: From procedure until 3 months post-procedure
Procedure-Related Complications
Time frame: During hospitalization
Postoperative delirium
Time frame: Within 30 days after procedure
Postoperative demans
Time frame: Within 30 days after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: During index hospitalization and at 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.